Customer reported that the blue, sterile, cotton or towels pwtb04-stm, from the ir neuro pack san44iruta/lot 375598 are shedding fibers onto various wires and catheters during a intracranial embolization.The towels were used for fluid absorption outside the drape.There was no injury or delay.No patient demographics were provided after attempts.Cardinal health is proactively filing a report for malfunction.
|
Supplemental report is being filed since the results of investigation are available.From the device history record, lot#20191112-23-sh was manufactured on 15th nov 2019.No exception was recorded in the device history record that could lead to the reported incident.Supplier reviewed records over the last 2 years, and no abnormal situation was found.A sample was not returned at the time of the investigation but a photo of lint was provided for review.According to supplier, or towel is made of cotton, so cotton fiber is a natural characteristic.Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).D.In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, no abnormal situation happened in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
|